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The Study Of Fluconazole For Vulvovaginal Candidiasis

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vulvovaginal Candidiasis

Intervention: Fluconazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

As for the indication of vulvovaginal candidiasis, a single oral administration of fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and topical therapies such as vaginal tablets, pessary and cream are used clinically. The purpose of this trial is to confirm the efficacy and safety of single oral administration of fluconazole 150 mg for the treatment of vulvovaginal candidiasis in Japanese patients.

Clinical Details

Official title: A Multicenter Open-label Non-comparative Study Of Fluconazole For The Treatment Of Vulvovaginal Candidiasis.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Therapeutic Outcome: Response Rate

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid

Secondary outcome:

Clinical Efficacy: Cure Rate

Clinical Efficacy: Cure and Improvement Rate

Mycological Efficacy: Eradication Rate

Total Scores for Clinical Symptoms

Maximum Observed Plasma Concentration (Cmax)

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight

Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight

Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid

Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Patients with clinical symptoms and signs of vulvovaginal candidiasis.

- Patients tested positive for Candida by fungal culture.

- Patients who can agree not to have intercourse up to 28 days after dosing.

Exclusion Criteria:

- Patients with a history of hypersensitivity to fluconazole.

- Patients with severe renal dysfunction.

- Patients with liver disorder.

Locations and Contacts

Mori Ladies Clinic, Fukuoka 810-0011, Japan

IZUMI Ladies' Clinic, Gifu 502-0914, Japan

Tetsu-Nakamura Obstetrics and Gynecology Department Internal Medicine, Kagoshima 892-0845, Japan

Women's Clinic Kamimura, Okayama 700-0901, Japan

Hayakawa Clinic, Osaka 542-0086, Japan

Sutou Ladies Clinic, Osaka 542-0081, Japan

Ai WOMEN'S CLINIC, Asahikawa, Hokkaido 070-8003, Japan

Shirokane Ladies' Clinic, Minato-ku, Tokyo 108-0071, Japan

Takane Medical Clinic, Shinagawa-ku, Tokyo 140-0013, Japan

Suzuran Clinic, Suginami-ku, Tokyo 167-0051, Japan

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: March 2013
Last updated: December 1, 2014

Page last updated: August 20, 2015

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